Events

TPS Micro Driver 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Instruments Div. of Stryker Corporation 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    66352
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0092-2014
  • 사례 시작날짜
    2013-10-02
  • 사례 출판 날짜
    2013-10-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-04-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122137
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Driver, wire, and bone drill, manual - Product Code DZJ
  • 원인
    It was discovered that the silicone potting failed to properly cure after undergoing the prescribed curing possess. the potting material is used to insulate, stabilize and provide a moisture barrier to the tps microdriver main printed circuit board assembly (pcba). inadequate cure of the silicone potting could potentially allow it to leak to the outside of the handpiece or cause an electrical ma.
  • 조치
    Stryker sent an Urgent Medical Device Correction Notification letter via overnight mail and interntion consignees via E-mail on October 2, 2013. The Urgent Notice identified the recalled product, the reason for the recall, potential adverse risks to health associated with the recall. Customers were instructed to: 1. Immediately review this Recall Notification 2. Locate, and quarantine, the units listed in this notification. Do not use the recalled TPS MicroDriver until it has been repaired. A list, of units shipped to your facility, is included on the attached Business Reply Form. 3. Return the enclosed Business Reply Form to confirm receipt of this notification and identify how many affected units are currently in your inventory. 4. If you have further distributed this product, please forward this letter and the attached Business Reply Form (BRF) to all affected locations. Please indicate each location on the BRF. 5. Fax the completed Business Reply Form to Stryker Instruments Regulatory Department, 866-521-2762. 6. Upon receipt of the Business Reply Form, Stryker will send you a pre-paid shipper to send your affected device(s) back to Stryker to be repaired. Unit will be repaired and returned to your facility 7. Send back all affected devices using the pre-paid shipper provided to you by Stryker. 8. If you require a loaner, please contact the Stryker Service Department at 888-308-1983. For questions regarding this recall call 269-389-4518.

Device

TPS Micro Driver
  • 모델명 / 제조번호(시리얼번호)
    10933, 11433, 11483, 20553, 30163, 31553, 40713, 40833, 41113, 50463, 60133, 60423, 90383, 110093, 110193, 1030133, 1030403, 1040413, 2010013, 2010123, 96090403, 96091343, 97020193, 97030013, 97030543, 97050243, 97060163, 97080033, 98010083, 98020703, 98030103, 98040213, 98060023, 98061033, 98070603, 98090023, 98090473, 98090503, 98101143, 98110323, 99010433, 99030253, 99050033, 99050383, 99060163, 99060423, 99061063, 99061283, 99070453, 99071293, 99080243, 99080483, 99090913, 99101273, 221303733, 326102033, 434909453, 500800103, 504900233, 631112793, 631414853, 700314923, 723606673, 725315933, 735502183, 813304543, and 921700523 .
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: US (nationwide) and countries of: Australia, Canada, France, Germany, Italy, Japan, Spain, Switzerland, and United Kingdom.
  • 제품 설명
    REF 5100-088, TPS Micro Driver, For Use with Stryker Total Performance System || Caution Federal Law (USA) restricts the device to use by or on the order of a physician || Driver, Wire and Bone Drill; The Stryker Total Performance System (TPS) is intended for use in the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental, orthopedic, maxillofacial, spinal, and plastic surgery. The instruments are also used in the placement of screws, wires, pins, and other fixation devices.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • 제조사 주소
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA